You are on page 1of 15

RAPID ADVICE

Use of antiretroviral drugs for treating pregnant women


and preventing HIV infection in infants
Version 2
WHO Library Cataloguing-in-Publication Data

Rapid Advice: use of antiretroviral drugs for treating pregnant women and preventing HIV infection in infants, November 2009.
Revised June 2010

1.Antiretroviral agents - pharmacology. 2.HIV infections - therapy. 3.HIV infections - prevention and control. 4.Disease transmission, Vertical - prevention and
control.
5.Pregnant women. 6.Guidelines. 7.Developing countries. I.World Health Organization.

ISBN 978 92 4 159893 4 (NLM classification: WC 503.2)

© World Health Organization 2009

All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva
27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; email: bookorders@who.int). Requests for permission to reproduce or translate WHO publications—
whether for sale or for noncommercial distribution—should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; email: permissions@who.
int).

The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the
World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or
boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement.

The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization
in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial
capital letters.

All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published
material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the
reader. In no event shall the World Health Organization be liable for damages arising from its use.

Printed in Switzerland

RAPID ADVICE: USE OF ANTIRETROVIRAL DRUGS FOR TREATING PREGNANT WOMEN AND PREVENTING HIV INFECTION IN INFANTS
RAPID ADVICE
Use of antiretroviral drugs for treating pregnant women
and preventing HIV infection in infants

VERSION 2 JUNE 2010

RAPID ADVICE: USE OF ANTIRETROVIRAL DRUGS FOR TREATING PREGNANT WOMEN AND PREVENTING HIV INFECTION IN INFANTS
RAPID ADVICE: USE OF ANTIRETROVIRAL DRUGS FOR TREATING PREGNANT WOMEN AND PREVENTING HIV INFECTION IN INFANTS
CONTENTS
1. Overview 4
1.1 Background 4
1.2 Why a revision? 4
1.3 Guiding principle 4
2. Recommendations at a glance 5
3. The revision process 5
3.1 Retrieving, summarizing and presenting the evidence 5
3.2 Consensus, external review and updating 5
3.3 Publication and timing 6
4. Adaptation, implementation and evaluation 6
5. Companion documents 6
6. Declaration of interest 6
7. Collaboration with external partners 7
8. Key recommendations 7
8.1 ART for HIV-infected pregnant women who need treatment for their own health 7
8.2 ARV prophylaxis for all HIV-infected pregnant women who do not Need treatment
for their own health 8
9. Annex 1 10

RAPID ADVICE: USE OF ANTIRETROVIRAL DRUGS FOR TREATING PREGNANT WOMEN AND PREVENTING HIV INFECTION IN INFANTS
1. Overview
1.1 Background
The World Health Organization (WHO) worked 5% in breastfeeding populations (from a background
on the revision of Antiretroviral Drugs for Treating risk of 35%) and to less than 2% in non-breastfeeding
Pregnant Women and Preventing HIV Infection in Infants: populations (from a background risk of 25%), and will
Recommendations for a public health approach, 2006, help promote improved maternal and child health and
through a series of coordinated efforts to review and survival. More effective interventions in resource-limited
synthesize emerging evidence. The key areas of review settings make it possible for low and middle income
are: countries to target the virtual elimination of MTCT and
paediatric HIV/AIDS, as has already been achieved in
a. when to start and what antiretroviral many countries.
therapy (ART) to give to pregnant
women living with HIV who are eligible These recommendations provide guidance to policy-
for ART; and makers and programme managers responsible for
b. when to start and what antiretroviral (ARV) national PMTCT programmes, and is a resource document
prophylaxis to give to pregnant women for health care workers involved in the prevention, care
who do not need ART for their own health, and treatment of pregnant women and their infants.
but need ARVs to reduce the risk of The guidance also provides a normative framework to
mother-to-child transmission (MTCT) of HIV. international and bilateral funding and implementation
and support agencies.
This evidence was assembled following systematic
reviews, GRADE profile analysis, consultation with key This Rapid Advice focuses on two key areas:
implementers, cost review, and peer review. 1. When to start and what ART to give to
pregnant women living with HIV who are
Various individuals were involved in the development eligible for ART; and
of these recommendations: the Core Writing Group
consisting of WHO staff and external experts, the full 2. When to start and what ARV prophylaxis to
Guidelines Review Committee, and the Peer Review give to pregnant women who do not need
Group. The members are listed in Annex 1. ART for their own health, but need ARVs to
reduce the risk of MTCT.
The aim was to identify evidence-based
recommendations that would be likely to deliver high
quality care and more effective PMTCT ARV interventions.
1.3 Guiding principles
The evidence and its quality, risks and benefits, The WHO guidelines on the use of ARV drugs for treating
acceptability, feasibility, cost and financial implication, pregnant women and preventing HIV infection in infants
were considered by the Guidelines Review Committee were revised in accordance with the following guiding
and the Peer Review Group, who agreed on a series of principles:
updated recommendations.
1. Women (including pregnant women) in need
of ARV drugs for their own health should
In advance of the release of the full revised guidelines,
receive life-long ARV treatment (ART).
WHO is releasing this Rapid Advice, which summarizes the
key recommendations. 2. A CD4 cell count available antenatally is critically
important for decision-making with regard to
1.2 Why a revision? maternal ART eligibility.
The availability of a significant amount of new evidence 3. Recommended interventions should be aimed at
on ARV prophylaxis to prevent MTCT, as well as new maximizing the effectiveness of reducing vertical
information on optimal timing for ART initiation HIV transmission, minimizing the side effects
(treatment eligibility) warrants development of revised for both mothers and infants, and preserving
2010 guidelines. Particularly important is the evidence future HIV care and treatment options.
indicating the benefits of increasing the number of
4. Effective postpartum ARV-based interventions will
pregnant women started on lifelong ART, and new data
allow safer breastfeeding practices.
indicating that extended ARV prophylaxis to mothers
or infants is effective in substantially decreasing the risk 5. Simple unifying principles for different country
of HIV transmission through breastfeeding. Revision of settings are needed.
the guidelines provides an important opportunity to
simplify and standardize current recommendations,
and to provide updated normative guidance for more
effective PMTCT interventions in both resource-limited
settings and globally. Once implemented, these
recommendations can reduce MTCT risk to less than

4 RAPID ADVICE: USE OF ANTIRETROVIRAL DRUGS FOR TREATING PREGNANT WOMEN AND PREVENTING HIV INFECTION IN INFANTS
2. Recommendations
at a glance
The PMTCT recommendations refer to two key a collaborative effort between UCSF, CDC and WHO. The
approaches: HIV/AIDS Cochrane Collaborative Review Group search
strategy was used for each of the four key questions.
1. Treatment: lifelong ART for HIV-positive women
in need of treatment. An informal two day meeting with key stakeholders,
cohosted by PEPFAR, was held in Washington in
2. Prophylaxis: short-term provision of ARVs, to September 2009. This meeting helped assess the
prevent HIV transmission from mother to child. feasibility of potential new recommendations and the
challenges that countries may face in revising their
This provides the basis for: national guidelines.
1. Earlier ART for a larger group of HIV-positive pregnant
women to benefit both the health of the mother A second feasibility assessment was done through a rapid
and prevent HIV transmission to her child assessment in the form of a structured questionnaire to
during pregnancy WHO country offices.

2. Longer provision of antiretroviral ARV Additional considerations on the feasibility of relevant


prophylaxis for HIV-positive pregnant women PMTCT interventions were provided through a
with relatively strong immune systems who do presentation on the health systems considerations of
not need ART for their own health. PMTCT programmes presented during the Guidelines
This would reduce the risk of HIV transmission review meeting.
from mother to child
Cost information and implications were prepared
3. Provision of ARVs to the mother or child to
by WHO for key ART regimens and ARV prophylaxis
reduce the risk of HIV transmission during
regimens taking into account the different pricing in low-
the breastfeeding period. For the first time,
income, lower-middle income and upper-middle income
there is enough evidence for WHO to recommend
countries. Pricing information was based on the Global
ARVs while breastfeeding.
Price Reporting Mechanism (GPRM) http://apps.who.int/
hiv/amds/price/hdd/. Cost implications of the proposed
3. The revision process recommendations were presented and discussed during
the Guidelines review meeting.
3.1. Retrieving, summarizing and GRADE evidence profiles will be included in the full
presenting the evidence guideline.
WHO convened an expert consultation in November
2008 to review new evidence accumulated since the 3.2 Consensus, external review
2006 guidelines. This consultation helped WHO to and updating
compile the evidence and make a decision that there
was enough new evidence to warrant the revision of the The Guidelines review meeting on the Use of Antiretroviral
2006 guidelines. Drugs for Treating Pregnant Women and Preventing HIV
Infection in Infants was held in Geneva from October
Following this initial meeting, WHO drafted the scope of 19-21, 2009. The meeting reviewed evidence around
work and developed PICO1 questions for the key areas the four key areas in different sessions. Each of the
of review. GRADE profiles were prepared for four PICO sessions included presentations on the related GRADE
questions: evidence, current and proposed recommendations,
cost implications, and the risk-benefit analysis of the key
a. when to start ART in pregnant women and what questions. Discussions were held both in plenary and in
to give to pregnant women eligible for ART group work sessions.
b. when to start ARV prophylaxis in pregnant The proposed recommendations were reviewed and
women, and what to give pregnant women the final recommendations were formulated taking
for ARV prophylaxis into consideration the quality of evidence, the balance
c. what to give newborn infants in the immediate between benefits and harms, the balance between
postpartum period; and values and preferences, cost, feasibility, and other factors.
If outcomes of the GRADE analysis were inconclusive,
d. what to give breastfeeding-exposed infants beyond other factors as listed above were taken into
the immediate postpartum period. consideration in making a recommendation. To reach
consensus, the group took into account each of the
Based on the PICO questions, systematic review of peer- factors listed above and went through the risk-benefit
reviewed literature and abstracts was performed through tables to make decisions on recommendations. In a
1 PICO is an acronym that describes the elements of a well-formed clinical
question. The structure includes: ‘P’ for the patient or population; ‘I’ for the
intervention of interest; ‘C’ for comparison; and ‘O’ for outcome

RAPID ADVICE: USE OF ANTIRETROVIRAL DRUGS FOR TREATING PREGNANT WOMEN AND PREVENTING HIV INFECTION IN INFANTS 5
few cases where there was no initial consensus, there the PEPFAR PMTCT/Peds technical working group, and
was further discussion and decisions were reached by WHO regional offices to plan for rapid dissemination
voting. The key recommendations were summarized in and implementation of the new guidelines. Much
«recommendation tables» according to the four main experience has been obtained from the dissemination of
questions, and included a summary of key factors that the previous guidelines, and active support for guideline
were considered in making the recommendations. revision at country level is needed. Key steps in the
dissemination include:
The summary recommendations were sent for peer
review to six independent peer reviewers and the six 1. Translation into at least 3 other languages (French,
WHO regional offices. They also received the risk-benefit Spanish and Russian). This will be in both hard
tables that included the strength of the evidence and copies and web documents.
the strength of the recommendation and were asked 2. Development of an adaptation guide, in
to provide feedback on whether they agreed with the conjunction with implementing partners.
recommendations or not, and if not why; and whether This adaptation guide will include a process
there were any key points that were not addressed that feedback document that will provide WHO
would be important to include. Feedback was received with important information on the quality,
in writing from all of the reviewers. Representing usefulness and impact of the guidelines.
different regions, countries and perspectives, the peer
review process confirmed overall strong support for the 3. Briefings, support and joint planning for
proposed recommendations. dissemination with IATT partners, PEPFAR, Global
Fund, etc.
Comments received from peer review were shared with
4. Regional workshops to disseminate the guidelines
the core writing group by teleconference. The draft
and support country adaptation. (Nearly all WHO
recommendations and recommendation tables were
regions have included this in their workplans
reviewed again, and finalized.
for 2010, and PEPFAR has provided specific
support for joint regional workshops.)
Based on all of the above mentioned steps, the summary
recommendations were finalized and submitted to the 5. Rapid country adaptation - WHO will work directly
WHO Guideline Review Committee for approval in early with 2-3 high burden countries to support the
November 2009. rapid adaptation and implementation of the new
guidelines, in order to learn first-hand how to
The current guidelines are to be reviewed in 2012, unless accelerate the process.
significant new evidence warrants a review process
earlier.

3.3 Publication and timing 5. Companion


This Rapid Advice on Use of Antiretroviral Drugs for Treating
Pregnant Women and Preventing HIV Infection in Infants
documents
will be published online in English and French. Simple tools to accompany the full guidelines are being
developed in collaboration with key implementing
Two guideline writers are assisting in developing the partners. These tools are designed to:
revised guidelines. After final clearance, publication • assist countries in the revision of the national
and dissemination is exepted to start in June or July PMTCT guidelines and
2010. The guidelines target national-level policy and • support the choice of regimen taking into account
decision-makers, programme managers and managers the resources and limitations within the country.
responsible for designing and implementing PMTCT
programmes, including ART for women. The first of these important tools is this rapid advice
document.

4. Adaptation,
6. Declarations
implementation and
of interest
evaluation Declaration of interest forms were collected from every
WHO is working closely with UN and other implementing member of each group. All individuals attending the
partners, as part of the IATT (InterAgency Task Team), Guidelines review meeting completed the required

6 RAPID ADVICE: USE OF ANTIRETROVIRAL DRUGS FOR TREATING PREGNANT WOMEN AND PREVENTING HIV INFECTION IN INFANTS
declaration of conflict of interest form. Altogether five the HIV-infected mother’s health and decreasing HIV
individuals declared some conflict of interest: L Kuhn, S transmission risk, in this group with the highest risk of
Luchters, R Shapiro, and L Guay each declared receiving mother-child HIV transmission.
research support in the past and present. None of the
participants received funding from pharmaceutical
companies. The support is mainly as research grants Table 1. Eligibility criteria for ART or ARV prophylaxis
from universities and government funding. The WHO in HIV-infected pregnant women
Secretariat felt that the declarations did not represent
significant conflicts (standard publicly-funded research CD4 cell count available
support) and would not unduly affect the individual’s
judgment or the outcome of the meeting. The CD4 <350 cells/mm3 CD4 >350 cells/mm3
declaration from E Nyankesha was not seen as a conflict ART ART
of interest. A Mushavi from the Peer review group
declared some conflict but the WHO Secretariat did not Regardless of clinical If symptomatic
feel that the magnitude of the disclosure warranted any stage (stage 3 or 4)
further clearance.

WHO clinical stage


7. Collaboration with Stage 1
Stage 2
ARV prophylaxis
ARV prophylaxis
external partners and Stage 3 ART
funding Stage 4 ART
There are no external collaborators specific to this Rapid RECOMMENDATION 2
Advice. However, several partners have been engaged in HIV-infected pregnant women in need of ART for their
the development of the guideline. All collaborations will own health should start ART irrespective of gestational
be detailed in the full guideline. age and continue throughout pregnancy, delivery and
thereafter. (See table 2)
Funding to support this work comes from PEPFAR and (Strong recommendation, moderate quality evidence)
UNAIDS.
Remarks: The timing of ART initiation for HIV-infected
pregnant women is the same as for non-pregnant women,

8. Key recommendations i.e. as soon as eligibility is established. The recommendation


places a high value on the health of the woman. It places
relatively low value on the potential risks for the mother and
8.1 ART for HIV-infected pregnant unborn infant.
women who need treatment RECOMMENDATION 3
for their own health In pregnant women in need of ART for their own
RECOMMENDATION 1 health, the preferred first-line ART regimen should
In pregnant women with confirmed HIV serostatus, include an AZT + 3TC backbone: AZT + 3TC + NVP
initiation of antiretroviral therapy for her own health or AZT + 3TC + EFV. Alternative regimens that are
is recommended for all HIV-infected pregnant women recommended include TDF + 3TC (or FTC) + EFV and
with CD4 cell count ≤350 cells/mm3, irrespective of TDF + 3TC (or FTC) + NVP2.
WHO clinical staging; and for all HIV-infected pregnant (Strong recommendation, low quality evidence)
women in WHO clinical stage 3 or 4, irrespective of
CD4 cell count. Remarks: The preferred ART regimens recommended for HIV-
(Strong recommendation, moderate quality evidence) infected pregnant women are the same as for non-pregnant
women. The recommendation places a high value on the
Remarks: The criteria for initiating ART for pregnant health of the mother and the benefit for reducing MTCT. It
women are the same as for non-pregnant women. The places relatively low value on the potential drug toxicity risks
recommendation places a high value on the health of the for the mother and unborn infant. The decision should be
woman and a relatively low value on the potential risks guided by the experience, availability and potential toxicity
and increased cost. Available data show that maternal ART of these regimens in pregnancy. EFV-based regimens should
during pregnancy and continued during breastfeeding is not be newly initiated during the first trimester of pregnancy
efficacious in reducing HIV transmission or infant death, (see also adult ART guidelines).
and is the most effective intervention for promoting
2 AZT: zidovudine; 3TC: lamivudine; NVP: nevirapine; EFV: efavirenz;
TDF: tenofovir; FTC: emtricitabine

RAPID ADVICE: USE OF ANTIRETROVIRAL DRUGS FOR TREATING PREGNANT WOMEN AND PREVENTING HIV INFECTION IN INFANTS 7
RECOMMENDATION 4 women would not start ARV prophylaxis at 14 weeks, but
Infants born to HIV-infected women receiving ART for the goal is for a majority of women to start during the 2nd
their own health should receive trimester, rather than the middle of the 3rd trimester
a) for breastfeeding infants: daily NVP or AZT from
birth until 4 to 6 weeks of age RECOMMENDATION 6
(Strong recommendation, moderate quality evidence) For the mother
For all HIV-infected pregnant women who are not
b) for non-breastfeeding infants: daily AZT or NVP from in need of ART for their own health, ARV prophylaxis
birth until 4 to 6 weeks of age option A consists of:
(conditional recommendation, low quality evidence) • antepartum daily AZT;
• sd-NVP at onset of labour*;
Remarks: The recommendation places a high value on • AZT + 3TC during labour and delivery*;
preventing perinatal transmission of HIV and providing • twice daily AZT + 3TC for 7 days postpartum*.
protection to the newborn infants in addition to the (Strong recommendation, low quality of evidence)
protection received from the mother’s ART regimen. Among * sd-NVP and AZT+3TC intra- and post-partum can be omitted if
breastfeeding infants, there is evidence that daily NVP for 6 the mother receives more than 4 weeks of AZT during pregnancy
weeks is efficacious in reducing HIV transmission or death
and infant mortality. Among non-breastfeeding infants, For the infant
there is no evidence assessing the efficacy of daily NVP for any In breastfeeding infants, maternal ARV prophylaxis
duration beyond a single dose. However, there is high quality should be coupled with sd-NVP at birth and then daily
of evidence that 6 weeks of daily infant AZT prophylaxis in administration of NVP to the infant from birth until one
conjunction with maternal antepartum AZT prophylaxis for week after all exposure to breast milk has ended.
more than 4 weeks significantly prevents MTCT of HIV. There (Strong recommendation, moderate quality of evidence)
is additional evidence that AZT for 6 weeks to the infant
provides significant protection when mothers have received In non-breastfeeding infants, maternal ARV prophylaxis
less than 4 weeks of antepartum prophylaxis. For mothers should be coupled with sd-NVP at birth and then daily
on ART, infant prophylaxis provides added early postpartum administration of NVP or AZT from birth until 4 to 6
protection, especially for mothers who start ART late, have weeks of age.
less than optimal adherence and have not achieved full viral (Conditional recommendation, low quality of evidence)
suppression.
Remarks: The maternal component of this ARV prophylaxis
8.2 ARV prophylaxis for all strategy is the same as the one recommended in the 2006
guidelines, although the revised recommendation is to start
HIV-infected pregnant women earlier during pregnancy (See Recommendation 5).
who do not need treatment For breastfeeding infants, the panel placed a high value
for their own health on an intervention that would allow safer breastfeeding
practices as long as the child is exposed to breast milk
RECOMMENDATION 5 in settings where breastfeeding is the norm. Although
All HIV-infected pregnant women who are not in need data are only available for the provision of NVP up to 6
of ART for their own health require an effective ARV months of age, the panel felt there is a need to provide
prophylaxis strategy to prevent HIV transmission to the ARV prophylaxis throughout the breastfeeding period to
infant. ARV prophylaxis should be started from as early minimize the risk of transmission. The panel also felt that the
as 14 weeks gestation (second trimester) or as soon as PMTCT ARV guidelines should not put a target duration for
possible when women present later in pregnancy or in breastfeeding; WHO will provide separate guidelines on HIV
labour or delivery. and infant feeding, in the context of ARVs.
(Strong recommendation, low quality of evidence)
As in Recommendation 4, for non-breastfeeding infants,
Remarks: Despite the lack of direct evidence showing that there is no evidence assessing the efficacy of daily NVP
starting prophylaxis earlier (than 28 weeks) is associated for any duration beyond a single dose. However, there is
with lower rates of intrauterine transmission, the panel high quality of evidence that 6 weeks of daily infant AZT
placed a high value on reducing the potential lost to follow- prophylaxis in conjunction with maternal antepartum AZT
up and delayed start of prophylaxis by waiting until the prophylaxis for more than 4 weeks significantly prevents HIV
third trimester, and recognized that there is some risk of MTCT. There is additional evidence that AZT for 6 weeks to
intrauterine transmission throughout pregnancy. Available the infant provides significant protection when mothers
observational studies show the benefits of the early start of have received less than 4 weeks of antepartum prophylaxis.
prophylaxis. This will minimize delays between HIV testing This conditional recommendation was primarily
in pregnancy and initiation of ARV prophylaxis. Given the based on programmatic issues that would facilitate its
median time of the 1st antenatal visit in most settings, most implementation in the field: countries should have the

8 RAPID ADVICE: USE OF ANTIRETROVIRAL DRUGS FOR TREATING PREGNANT WOMEN AND PREVENTING HIV INFECTION IN INFANTS
option of using NVP or AZT prophylaxis in infants; 6 weeks is Table 2 summarizes the two recommended ARV prophylaxis
also the first immunization visit for children in most settings, options for HIV-infected women who are eligible for ART:
which implies that they will be seen on site at that age. • Option A: Maternal AZT
• Option B: Maternal ARV prophylaxis
RECOMMENDATION 7
For the mother There is a strong benefit of providing effective
For all HIV-infected pregnant women who are not and sustained prophylaxis to women not eligible
eligible for ART, ARV prophylaxis option B consists of for ART during pregnancy, labour and delivery,
triple ARV drugs provided to the pregnant women as well as throughout breastfeeding in settings
starting from as early as 14 weeks of gestation until where breastfeeding is the preferred practice. Both
one week after all exposure to breast milk has ended. recommended options provide significant reduction of
The recommended regimens include: the MTCT risk. There are advantages and disadvantages
• AZT + 3TC + LPV/r 3 for both options, in terms of feasibility, acceptability and
• AZT + 3TC + ABC4 safety for mothers and infants, as well as cost. The choice
• AZT + 3TC + EFV for a preferred option should be made at a country level,
• TDF + 3TC (or FTC) + EFV bearing in mind these advantages and disadvantages.
(Strong recommendation, moderate quality of evidence)
3
LVP/r: lopinavir/ritonavir;
4
ABC: abacavir

For the infant


In breastfeeding infants, the maternal triple ARV
prophylaxis should be coupled with the daily
administration of AZT or NVP from birth until 4 to 6
weeks of age.
(Strong recommendation, low quality of evidence)

In non-breastfeeding infants, the maternal triple


ARV prophylaxis should be coupled with the daily
administration of AZT or NVP from birth until 4 to 6
weeks of age.
(Conditional recommendation, very low quality of
evidence)

Remarks: The provision of maternal triple ARV prophylaxis


during pregnancy in women who are not eligible for ART
results in very low intrauterine and peripartum transmission
rates. A high value is also placed on the simplicity of the
intervention as it contains only one maternal and one infant
regimen and may be available as a single daily fixed-dose
combination.

For breastfeeding infants, available data suggest that


maternal triple ARV prophylaxis started in pregnancy and
continued during breastfeeding is efficacious in reducing
HIV transmission and HIV transmission or infant death. The
panel placed a high value on providing an intervention that
would allow safer breastfeeding practices for as long as the
child is exposed to breast milk.

For non-breastfeeding infants, the conditional


recommendation was primarily based on programmatic
issues that would facilitate its implementation in the field: 6
weeks is also the first immunization visit for children, which
implies that they will be seen on site at that age.

RAPID ADVICE: USE OF ANTIRETROVIRAL DRUGS FOR TREATING PREGNANT WOMEN AND PREVENTING HIV INFECTION IN INFANTS 9
Table 2. ARV prophylaxis options recommended for HIV-infected pregnant women who do not need treatment for
their own health

Option A: Maternal AZT Option B: Maternal triple ARV prophylaxis


MOTHER MOTHER
• Antepartum AZT (from as early as 14 weeks Triple ARV from 14 weeks until one week after all
gestation) exposure to breast milk has ended
• sd-NVP at onset of labour* • AZT + 3TC + LPV/r
• AZT + 3TC during labour and delivery* • AZT + 3TC + ABC
• AZT + 3TC for 7 days postpartum* • AZT + 3TC + EFV
* sd-NVP and AZT+3TC can be omitted if mother receives >4 • TDF + 3TC (or FTC) + EFV
weeks of AZT antepartum
INFANT INFANT
Breastfeeding infant Breastfeeding infant
Sd-NVP at birth plus daily NVP from birth until one AZT or NVP from birth until 4 to 6 weeks
week after all exposure to breastmilk has ended
Non-breastfeeding infant
Non-breastfeeding infant AZT or NVP from birth until 4 to 6 weeks
Sd-NVP at birth plus AZT or NVP from birth until 4
to 6 weeks

9. Annex 1
WORLD HEALTH ORGANIZATION
Guidelines Committee Review Meeting on the Use of Louise Kuhn
Antiretroviral Drugs for Treating Pregnant Women Gertrude H. Sergievsky Center
and Preventing HIV Infection in Infants - 2009 version College of Physicians and Surgeons
Columbia University, New York, USA
Château de Penthes, Geneva, Switzerland, Ik24@columbia.edu
19-21 October 2009
Marc Lallemant
LIST OF PARTICIPANTS Programs for HIV Prevention and Treatment (PHPT)
29/7-8 Samlan Road, Soi 1 - Prasing, Muang, Chiang Mai 50200,
CONTENT (PMTCT) EXPERTS Thailand
marc3@phpt.org
Elaine Abrams
The International Center for AIDS Care and Treatment Programs James McIntyre
Mailman School of Public Health Perinatal HIV Research Unit
722 West 168th Street University of the Witwatersrand
New York, NY 10032, USA Chris Hani Baragwanath Hospital
eja1@columbia.edu PO Bertsham, Johannesburg 2013
South Africa
François Dabis mcintyre@pixie.co.za
Unité INSERM 330
Institut de Santé Publique, Epidémiologie et Développement Lynne M. Mofenson
(ISPED) National Institutes of Health
Université Victor Segalen Bordeaux 2, 6100 Executive Boulevard, Room 4B11
33076 Bordeaux Cedex, France Rockville, MD 20852, USA
Francois.Dabis@isped.u-bordeaux2.fr LM65D@nih.gov

Laura A. Guay Roger Shapiro


Elizabeth Glaser Pediatric AIDS Foundation Harvard Medical School
1140 Connecticut Ave. NW, Suite 200 110 Francis Street, Suite GB
Washington, DC 20036, USA Boston, MA 02215, USA
lguay@pedaids.org rshapirosph.harvard.du

10 RAPID ADVICE: USE OF ANTIRETROVIRAL DRUGS FOR TREATING PREGNANT WOMEN AND PREVENTING HIV INFECTION IN INFANTS
Jeffrey S. A. Stringer Nipunporn Voramongkol
University of Alabama at Birmingham Maternal and Child Health Group
Center for Infectious Disease Research in Zambia (CIDRZ), Department of Health
Lusaka, Zambia Ministry of Public Health
jeff.stringer@cidrz.org Tivanon Rd., Muang District
Nonthaburi 11000
Thailand
COUNTRY REPRESENTATIVES/ PROGRAMME EXPERTS job8018@yahoo.com
Marcelo Araújo de Freitas
Care and Treatment Division METHODOLOGISTS
STD and Aids Department
Ministry of Health, Brazil Health systems:
SAF Sul Trecho 02, Bloco F, Torre 1, Pierre Barker
Edifício Premium, Térreo, Sala 12 Department of Paediatrics
CEP: 70070-600 - Brasília DF University of North Carolina
Brazil Chapel Hill, NC 27516, USA
marcelo.freitas@saude.gov.br Pierre_barker@med.unc.edu

Kevin M. De Cock GRADE expert:


Centers for Disease Control and Prevention (CDC) Nancy Santesso
KEMRI, Mbagathi Road Department of Clinical Epidemiology and Biostatistics,
Off Mbaganthi Way, Nairobi McMaster University
Kenya 1200 Main Street West
kdecock@ke.cdc.gov Hamilton, ON L8N 3Z5
Canada
Nonhlanhla Rosemary Dlamini santesna@mcmaster.ca
Deparment of Health
Private Bag X 828 Pretoria 0001 IMPLEMENTING PARTNERS
Hallmark Building, Room 1513
235 Proes street, Pretoria 0002 Omotayo Bolu
South Africa PMTCT Team,
DlamiR@health.gov.za Global AIDS Program, CDC
1600 Clifton Road
Svitlana Komar Atlanta, GA 30333
Centre «Clinic for Treatment of HIV-infected Children» USA
Chornovola str., 28/1, Kiev, 01135 obb3@cdc.gov
Ukraine
skomar@yandex.ru Margaret Brewinski
USAID Office of HIV/AIDS
Dorothy Mbori-Ngacha 1300 Pennsylvania Ave, NW
University of Nairobi (Kenya) Washington, D.C. 20523-3600
Dept. of Pediatrics & Child Health USA
P.O. Box 19676, Nairobi mbrewinski@usaid.gov
Kenya
Dngacha@cdcnairobi.mimcom.net René Ekpini
dngacha@ke.cdc.org PMTCT - Pediatric care and treatment
Health Section, Program Division
Elevanie Munyana UNICEF
Clinical Prevention Department 3 United Nations Plaza
PMTCT at TRAC Plus Ministry of Health New York, NY 10017
P.O. Box 84, Kigali USA
Rwanda rekpini@unicef.org
MunyanaE@tracrwanda.org

Sarah Shalongo
Paediatric ARV
Ministry of Health and Social Services
Harvey Street, Windhoek
Namibia

Florence Soroses
Global Fund
Ministry of Health and Social Services
Harvey Street, Windhoek
Namibia
FSoroses@globalfund.com.na

RAPID ADVICE: USE OF ANTIRETROVIRAL DRUGS FOR TREATING PREGNANT WOMEN AND PREVENTING HIV INFECTION IN INFANTS 11
CIVIL SOCIETY / PLWHA Isseu Diop-Toure (AFRO)
Regional Office for Africa
Jane Mwirumubi Brazzaville, Republic of Congo
ICW East Africa Tagore Crescent diopi@afro.who.int
Plot 15, Kamwokya, Kampala
Uganda Ying-Ru Lo
jane_mwirumubi@yahoo.co.uk Prevention in the Health Sector
Department of HIV/AIDS
Portia Nomzuzu Ngcaba loy@who.int
7.16 Goodhope Road
Vuyo Gardens , Amalinda Eleonora Marini
East London 5247 marinie@who.int
South Africa
portia@tac.org.za Françoise Renaud-Théry
Systems Strengthening and HIV
Department of HIV/AIDS
GRADE REVIEWERS theryf@who.int
Jaco Homsy Nigel Rollins
Institute for Global Health Newborn and Child Health and Development
University of California, San Francisco Department of Child and Adolescent Health and Development
50 Beale St rollinsn@who.int
San Francisco, CA 94105
USA Charles Sagoe-Moses (AFRO)
jhomsy@psg.ucsf.edu Regional Office for Africa
Brazzaville, Republic of Congo
Jennifer S. Read sagoemosesc@whoafr.org
National Institutes of Health (NIH)
Executive Building, Room 4B11C Nathan Shaffer
6100 Executive Boulevard MSC 7510 Prevention in the Health Sector, PMTCT
Bethesda, MD 20892-7510 Department of HIV/AIDS
USA shaffern@who.int
jennifer_read@nih.gov
Tin Tin Sint
George Rutherford Prevention in the Health Sector, PMTCT
Institute for Global Health Department of HIV/AIDS
University of California, San Francisco sintt@who.int
50 Beale St, San Francisco, CA 94105
USA Isabelle de Vincenzi
grutherford@psg.ucsf.edu Control of Sexually Transmitted and
Reproductive Tract Infections
Amy Sturt Department of Reproductive Health and Research
Stanford University devincenzii@who.int
300 Pasteur Drive, S-101
Stanford, CA 94305 Marco Vitoria
USA Antiretroviral Treatment and HIV Care
amysturt@gmail.com Department of HIV/AIDS
vitoriam@who.int
WHO SECRETARIAT
20 Avenue Appia
CH-1211 Geneva 27
Switzerland

Boniface Dongmo Nguimfack


Strategic Information
Department of HIV/AIDS
dongmonguimfackb@who.int

Siobhan Crowley
Antiretroviral Treatment and HIV Care
Department of HIV/AIDS
crowleys@who.int

12 RAPID ADVICE: USE OF ANTIRETROVIRAL DRUGS FOR TREATING PREGNANT WOMEN AND PREVENTING HIV INFECTION IN INFANTS
RAPPORTEURS (Guideline writers) CORE WRITING GROUP

Renaud Becquet James McIntyre (Expert)


INSERM, Unit 897 François Dabis (Expert)
Research Centre in Epidemiology and Biostatistics Lynne M. Mofenson (Expert)
Université Victor Segalen Bordeaux 2
146, rue Léo Saignat
Ying-Ru Lo (WHO)
33076 BORDEAUX Cedex Nathan Shaffer (WHO)
France Tin Tin Sint (WHO)
Renaud.Becquet@isped.u-bordeaux2.fr Marco Vitoria (WHO)
Siobhan Crowley (WHO)
Stanley Luchters Isabelle de Vincenzi (WHO)
International Centre for Reproductive Health Stanley Luchters (Writer)
Department of Obstetrics and Gynaecology Renaud Becquet (Writer)
Ghent University
De Pintelaan 185– P3, 9000 Ghent
Belgium
stanley.luchters@ugent.be

EXTERNAL PEER REVIEWERS

Sostena Romana
Global PMTCT Initiative
Clinton Foundation HIV/AIDS Initiative
Boston, USA
sromano@clintonfoundation.org

Angela Mushavi
PMTCT and Pediatric Treatment
CDC - Namibia and Namibia MOH
mushavia@na.cdc.gov

Suna Balkan
Médecins Sans Frontières
Medical Department MSF Paris
8, rue Saint-Sabin
75011 Paris, France
sbalkan@msf.org

Mary Glenn Fowler


Makere University
Johns Hopkins University Research Collaboration
Kampala, Uganda
mgfowler@mujhu.org

Marc Bulterys
CDC China
Beijing, China
Zbe2@cdc.gov

Landry Tsague
UNICEF - Rwanda
ltsague@unicef.org

RAPID ADVICE: USE OF ANTIRETROVIRAL DRUGS FOR TREATING PREGNANT WOMEN AND PREVENTING HIV INFECTION IN INFANTS 13

You might also like